MAUDE Adverse Event Report: ROI CPS, LLC REGARD; BUNDLE DR CHAUVIN CV MERCY ROGERS

Model Number	CV00214Q
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A non-sterile brasseler sternal saw blade and a non-sterile specimen cup was added to this kit as a sub item in place of the sterile version.The kit is not sterilized prior to distribution, so the kit contents are required to be sterile prior to adding to the kit.Both items are required to be sterile for use, but were distributed to the direct account as non-sterile.

• Brand Name: REGARD
• Common Device Name: BUNDLE DR CHAUVIN CV MERCY ROGERS
• Manufacturer (Section D): ROI CPS, LLC; 3000 east sawyer road; republic MO 65738
• Manufacturer (Section G): ROI CPS, LLC; 3000 east sawyer road; republic MO 65738
• Manufacturer Contact: cheyenne stewart ; 3000 east sawyer road; republic, MO 65738 ; 4176473205
• MDR Report Key: 14736401
• Report Number: 3014527682-2022-00009
• Device Sequence Number: 2350744
• Product Code: OEZ
• UDI-Device Identifier: 10194717113249
• UDI-Public: 10194717113249
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: CV00214Q
• Device Catalogue Number: 830019017
• Device Lot Number: 92612
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 301452768206172022008C
• Patient Sequence Number: 1
• Patient Sex: Unknown